Infectious Diseases News Alerts

• Alert Cell-Based Quadrivalent Flu Vaccine Recommended by EMA Panel The EMA CHMP has recommended granting marketing authorization for Flucelvax Tetra (Seqirus Netherlands BV), a quadrivalent cell-based influenza vaccine.
  International Approvals, October 2018
• Alert EU Panel Recommends Marketing Authorization for Dengue Vaccine The EMA CHMP has recommended marketing authorization for a dengue tetravalent vaccine against dengue virus serotypes 1, 2, 3, and 4.
  International Approvals, October 2018
• Alert FDA Approves Revcovi for Adenosine Deaminase SCID The US Food and Drug Administration has approved elapegademase-lvlr for the treatment of adults and children with adenosine deaminase severe combined immune deficiency.
  FDA Approvals, October 2018
• Alert FDA Expands Gardasil to Include Adults Up to Age 45 The expanded age range for Gardasil 9 is an important opportunity to help prevent HPV-related diseases and cancers in a broader age range, the FDA said.
  FDA Approvals, October 2018
• Alert PRAC Again Warns Against Dolutegravir Use During Pregnancy The European Medicines Agency has confirmed its earlier precaution regarding the use of dolutegravir in women who are or who could become pregnant; it expects to make final recommendations next year.
  News Alerts, October 2018
• Alert PRAC Recommends Restrictions on Fluoroquinolone, Quinolones The new restrictions follow a review of rare but disabling and potentially long-lasting side effects, mainly involving muscles, tendons, bones, and the nervous system.
  News Alerts, October 2018
• Alert FDA Clears Omadacycline (Nuzyra) for Two Infections Omadacycline is a modernized tetracycline with broad-spectrum activity that is designed to overcome tetracycline resistance.
  FDA Approvals, October 2018
• Alert FDA Approves Sarecycline for Moderate to Severe Acne The FDA has approved sarecycline (Seysara, Almirall) for patients aged 9 years and older with inflammatory lesions associated with non-nodular moderate to severe acne vulgaris.
  FDA Approvals, October 2018
• Alert EMA Panel Backs Two New HIV Drugs Pifeltro contains doravirine, a new nonnucleoside reverse transcriptase inhibitor, and Delstrigo is a fixed-dose combination of doravirine, lamivudine, and tenofovir disoproxil fumarate.
  International Approvals, September 2018
• Alert New Antibiotics for Europe: CHMP Likes Vabomere, EC Clears Xerava Vabomere combines meropenem and vaborbactam for treatment of complicated UTIs and other infections; Xerava (eravacycline) is for complicated intra-abdominal infections.
  International Approvals, September 2018
• Alert Clinicians Advised to Prep for 'Huge Challenge' From Florence Disaster aid organization urges clinicians to reach out to fragile patients, as hospitals and aid organizations prepare for what one governor says will be a 'marathon, not a sprint.'
  Medscape Medical News, September 2018
• Alert FDA Clears New Immune Globulin for Measles, Hep A, Exposure GamaSTAN (immune globulin [human]) is for prophylaxis following exposure to hepatitis A and prevention of measles in susceptible individuals exposed fewer than 6 days previously.
  FDA Approvals, September 2018
• Alert FDA Approves Two New Drugs for HIV Pifeltro contains doravirine, a new non-nucleoside reverse transcriptase inhibitor, and Delstrigo is a fixed-dose combination of doravirine, lamivudine, and tenofovir disoproxil fumarate.
  FDA Approvals, August 2018
• Alert FDA Warns of Serious Genital Infection With SGLT2 Inhibitors The agency has received reports of 12 cases of necrotizing fasciitis of the perineum in patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors, including five women.
  News Alerts, August 2018
• Alert FDA Approves New Antibacterial Eravacycline (Xerava) The fluorocycline antibiotic is recommended for treatment of adults with complicated intra-abdominal infections.
  FDA Approvals, August 2018
• Alert FDA Approves Lenvatinib (Lenvima) for Liver Cancer The oral therapy lenvatinib joins sorafenib as the only drugs approved for first-line treatment of patients with unresectable hepatocellular carcinoma.
  FDA Approvals, August 2018
• Alert FDA: Don't Use Azithromycin for Lung Condition in Cancer Patients The FDA warns of an increased risk for relapse of hematologic malignancy and for death when azithromycin is used to prevent bronchiolitis obliterans syndrome in hematopoietic stem cell transplant patients.
  News Alerts, August 2018
• Alert Antibacterial Eravacycline (Xerava) Gets Thumbs Up From EMA Panel The fluorocycline antibiotic is recommended for treatment of adults with complicated intra-abdominal infections.
  International Approvals, July 2018
• Alert FDA OKs Tafenoquine (Krintafel) to Prevent Malaria Relapse Tafenoquine is the first single-dose medicine to prevent the relapse of Plasmodium vivax malaria and marks a major contribution toward malaria eradication.
  FDA Approvals, July 2018
• Alert FDA Approves Plazomicin (Zemdri) for Urinary Tract Infections Achaogen Inc said on Tuesday U.S. health regulators cleared its antibiotic plazomicin (Zemdri) to treat adults with complicated urinary tract infections, but declined approval for treating bloodstream infections.
  FDA Approvals, June 2018